Parexel Blog
Parexel Blog
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Learn MoreInsights that accelerate timelines for patients in need
What if you could shorten enrollment timelines in rare disease clinical trials, not by enrolling patients in the study’s control arm, but by using data already stored in healthcare...
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Learn MoreA Complete Life Sciences Platform...It’s About Time.
Chances are, we will all be a patient at some point in our lives. As mothers, fathers, sisters, brothers and friends, we realize that time is precious, whether it be attending our children’s...
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Learn MoreImagine if… we all focused every day on the impact we can make by bringing new treatments to patients more quickly.
Over the course of my career, I’ve had the privilege to work in many roles across the healthcare landscape. Regardless of the role, I’ve always focused my...
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Learn MoreFDA Needs To Know How 503B Compounders Work
FDA recently published a notice in the Federal Register regarding proposals to collect information during proposed research initiatives to understand challenges and opportunities encountered...
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Learn MoreFDA & EMA Joint Report on Early Access Pathways
FDA recently published in coordination with the European Medicines Agency (EMA) a report from a joint FDA-EMA workshop with stakeholders on supporting product quality development in early access...
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Learn MoreWorkforce Readiness: Cultures, Tools and Skills Needed by Organizations and Employees to Drive Innovation in Drug Development
This article was originally published as a whitepaper in Pharmaceutical Executive. Despite significant investment in pharmaceutical research and development (R&D),...
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Learn MoreCBER Launches CATT to Facilitate Innovation
CBER Advanced Technologies Team (CATT) is a new program designed to address regulatory challenges associated with development of advanced technologies for manufacturing and testing of CBER...
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Learn MoreRIM Blog Series – Part 4: The Special Relationship Between Product and Process Data
In my previous articles I talked about the history of RIM, structural must-haves, and provided a quick list of these features for a RIM system. If you missed them, you can find all the...
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Learn MoreHow CAR-T cell and gene therapies are redefining the traditional pharmaceutical pricing and reimbursement model
Very high prices plus limited immature data – the perfect payer storm Several emerging classes of transformational therapies, such as CAR-T cell and gene therapies, offer potentially curative...
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Learn MoreHeart Failure Trial Endpoints: Public Feedback on the Recent FDA Draft Guidance
The FDA recently released a draft guidance titled, “Treatment for Heart Failure: Endpoints for Drug Development.” This is a very informative document, since a main reason why FDA drafted it is to...
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Learn MoreNew Zealand Consultation on Proposed Warning Statements for Allergens in Medicines
Medsafe opened a public consultation on 27th June, they are proposing that manufacturers of medicines and related products include substances that may cause an allergic reaction on their...
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Learn MoreAll EU Members Have Now Joined!
The pharmaceutical facility current Good Manufacturing Practice (cGMP) inspections are the key to ensure the quality of drugs/medicines for the patients around of the world. While it is critical...
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Learn MoreRIM Blog Series - Part 3: Critical Features for a Successful RIM Platform
In my previous articles (Part 1, Part 2) we talked about the history of RIM and structural must-haves for a RIM system. It’s also important to know the questions that will be asked of the data as...
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Learn MoreFormer FDA expert provides valuable advice on INTERACT programs for CBER products
Many sponsors of CBER-regulated products are familiar with pre-IND meetings, but there’s a new program called INTERACT, which stands for Initial Targeted Engagement for Regulatory Advice on CBER...
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English Requirement for FDA GMP Documents
Generally, overseas manufacturers in non-English speaking countries have their GMP documentation in the local language so that the staff working at the facility are able to read and understand the...
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#ParexelWithPride - Employee contributes to the landmark ruling in Botswana
On Tuesday, June 11, the High Court of Botswana issued a unanimous decision decriminalizing same-sex sexual conduct between consenting adults. The Southern Africa Litigation Centre (SALC) hailed...
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RIM Blog Series - Part 2: Mind the gap
As discussed in my previous paper, RIM started about 15 years ago and is a discipline that supports Life Sciences Regulatory Processes. In 2003, capturing Regulatory information was a...
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Learn MoreImproving the Odds of Success in Prostate Cancer Therapy Development
In recognition of Men’s Health Month, Parexel offers a deep dive into the challenges of developing therapies for prostate cancer. Despite significant research advances, prostate cancer remains...
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Learn MoreThank you for Joining with Parexel to Mark International Clinical Trials Day
Over the last few weeks Parexel has been celebrating International Clinical Trials Day, aimed at raising awareness of the impact of clinical trials and honoring the patients participating in...
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Bispecific Antibody Development Program Guidance
Earlier this month FDA released a draft guidance called “Bispecific Antibody Development Programs”. This is a welcome addition to FDA’s set of guidance documents for biotechnology...
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